Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder

Peking University Sixth Hospital

Status: Completed

Conditions: Depressive Disorder, Major

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT04013464

2014-4-2113

Details and patient eligibility

About

The main objective was to compare the differences of PSG parameters and plasma melatonin levels before and after treatment with escitalopram for 8 weeks. Polysomnography (PSG) was detected over a night and blood samples were collected at 4 h intervals for 24 h from 13 male healthy controls and 13 male MDD patients before and after treatment with escitalopram for 8 weeks. The outcome measures included the levels of plasma melatonin, PSG parameters (include sleep architecture and power analysis) and scales.

Full description

1. Design and participants: The patients with MDD were screened from the hospital, age- and gender-matched healthy controls were recruited by advertising from the community who signed written informed consent before participation.
2. Assessments: The 17-item Hamilton Depression Rating Scale (HRSD-17) , Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression-Severity scale (CGI-S), and 14-item Hamilton anxiety scale (HAMA) were assessed at baseline and after 8 weeks' treatment with escitalopram for patients with MDD. As for healthy volunteer, these measures were evaluated only once. In addition, all participants were assessed Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI).
3. Treatment: Each patient was provided with escitalopram.
4. Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
5. Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
6. Analysis the PSG architecture and power ratio.

Enrollment: 31 patients

Sex: Male

Ages: 22 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of MDD;
2. Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
3. Male patients aged between 18 and 45 years

Exclusion criteria

1. Significant suicide risk by HRSD suicide scores > 2;
2. Accompanied with psychiatric symptoms;
3. Treated with MECT within 6 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 1 patient group

MDD and Health Control

Experimental group

Description:

MDD in open label

Treatment:

Drug: Escitalopram